QA Investigations Lead
Competitive compensation package and growth opportunities
Working with industry leaders and partnering with top competitors
About Our Client
Leading global bio-pharmaceutical company based in New Jersey focused on CAR-T cell therapy. Part of a global strategic collaboration working with industry experts and top competitors to advance their practice.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
· Support compliance activities for site Quality Operations in accordance with company standards, procedures and cGMPs
· Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues
· Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints
· Support regulatory inspections and audits by ensuring inspection readiness within facility
· Perform analysis on quality indicating data and identifying trends
· Provide oversight for trending of quality compliance metrics
· Work in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning
The Successful Applicant
Ideal candidate will have:
· A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required
· A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy
· Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices
What's on Offer
Competitive salary and growth opportunities, alongside working with industry leaders.